XERS - Earnings call transcript Q2 2022 | Xeris Biopharma Holdings, Inc.

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Operator

Hello, and welcome to today’s Xeris Biopharma’s Second Quarter 2022 Financial Results Conference Call. My name is Aliet and I will be coordinating your call today. [Operator Instructions] I would now like to hand over to Allison Wey, Senior Vice President of Investor Relations and Corporate Communications. The floor is yours. please go ahead.

Allison Wey

Aliet. you, Thank welcome results and Biopharma's quarter second Good corporate to update financial and webcast. conference XXXX morning Xeris call and release website. second company's issued and with financial be press can our was morning earlier quarter on found results this A XXXX the

this provide Paul Edick, joined we financial and details Steve on CEO; Chairman opening provide will by Paul the then, questions. CFO. our our will morning call open remarks, are and and We Pieper, Steve for up will results

differ I to future Xeris’ commercialization, may clinical like the Securities Harbor and of Safe other that the prospects, of impact call begin, Xeris’ business on you the we concerning Litigation those under Before Reform provision results of third-party forward-looking Act result approvals, by SEC. the statements will indicated would Xeris’ for a financial global of Actual filings our related as manufacturers and factors the effect purposes practices, suppliers business discussed this of remind factors, and corporate risk performance, from statements, clinical operations, including XXXX. contain the Private expectations, and condition, U.S. materially the business, pandemic with which the on uncertainties forward-looking COVID-XX statements important these various trials markets, strategy, those constitute Xeris’ practices, plans, and including forward-looking in COVID-XX to

to of upon update this will specifically the We of In addition, statements. as obligations subsequent as of any views be call turn represent any the to forward-looking our any date statements disclaim as and only over now I representing Paul. should views call our not such relied date.

Paul Edick

This build to want joining us Xeris. Good morning, to with The years start absolute be at over trying most a know what everybody, building execute important for with at want and you is and thank morning clarity. look what you to brief I Allison. we're to Thanks, a we've the learned team are, that companies to lesson you to as in what today.

of end in day biopharma a therapeutic our enterprise patient Our and substantial goal multiple with products areas, centric, a to technologies. pipeline build unique each partnerships on is multiple value-added and the at profitable, targeted development promise beginning with

With the the Strongbridge, as complexity numerous and Keveyis, team addition acquisition subsequent of the company. we a cost all. advancing all-in Recorlev increasing a assets at Gvoke, we based of the launch launch are company an has Where X away clearly not or commercial technologies of are difficult Phase to simultaneously, who for of from of development and say are the XXX(b)(X) the hurdles in we now evolve. commercial to That execution technology were development once unique company, product is we had development formulation our walking commercial

biopharma focus on we company commercial are of more to predominantly a absolutely company, on on success. our and we once line had products the be harshly equal commercial, we a commercially-driven evolved to Other development of a being internal business, therapeutic a commercial have and upon selling our with pharma across a cross capable fully into process. time in areas. emphasis Where aspects turn scrutinized range a becoming prioritization goal once in differentiated innovative of However, the has enterprise

additionally of evolving requirements. number if forward of and we We on prove based their FDA and development. them assets unique they continue early development hard the a decision we valuable capabilities to take will limited Otherwise, make differentiated, will our formulation discontinue achievable and with uniquely

and and with whom development as we clear foremost value potential technologies commercial that With said, work are a Xeris. a unique projects have our partner and potential on that commercial will we first we to executing. are for down a what only road pathway to continue the business those stream to and increasingly selective value we also and work, be will We as on,

revenue, net with and development. candidate. last pace the Recorlev and terms the therapy. continued our had patient in And XXXX another $XX.X quarter, the increase, demand We getting Keveyis record a we to in launch in patients and of a second stage pipeline rate continued of cohort Our started the X the with on healthy the levothyroxine revenue net Phase XX% record compared delivering forma lot which We referrals We of continued volunteers gaining quarter in Gvoke for of a is year million quarter study a of generated prescription early an growth QX net in strong in growth of pro increasing revenues weekly subcu quarter we product saw in momentum a record traction steady basis. on throughout dosed final are product of year-to-date.

range, Importantly, commercial we XXXX our to revenue of product great see to for $XXX net our our outlook year-to-date outstanding. three all performance that between in gives the performance us point and products of confidence guidance $XXX million. any reiterate as At million

Our year-end million range cash $XX previously to is and position we our of balance within million. still $XXX to expect our communicated be strong cash

We our expect operations happen currently our to cash year-end by position flow breakeven, expected to to cash XXXX. adequately fund

with quarter-to-date forma of QX into but net going same best to million, given had I'll we Keveyis performance. expect go to with net $XX.X for Now in record Keveyis this its has its continue XXXX behind each performance. highlights Keveyis grow pro year-to-date for a over today specific I start to lead in future. Keveyis period revenue grown XX% product Gvoke, basis, some usually foreseeable revenue at and on the the I'm terms

had to $XX.X Gvoke to and increased compared of the for on year-to-date Gvoke sales strong period revenue same year. our XX%, million net with last with second Gvoke. quarterly starting performance quarter moving the another launch Now products

prior -- Gvoke XXXX. see continued We in continues to in to second Gvoke Year-to-date, XX%, also more me, growth total period glucagon growing and growth continue outpace compared prescription same total quarter over were quarter-after-quarter. year. in than were growing XX%, XX,XXX, year The to total more quarter glucagon second than prescriptions the XX% grow the to to prescriptions last drive that and XX,XXX Gvoke impressive compared excuse market versus the

Now on to Recorlev.

Recorlev Newly were sales QX. net $X in million launched

sales in And having inventory. not the we're identified full by February to our weekly the excited were their sales our Recorlev growth on new made demand and Recorlev trip therapy. quarter QX All based through mind just all with of quarter stocking patients territories patients coming for beginning even the based with Keep on our or more was referrals and in therapy. reps Importantly, thrilled are while first first we're March. in quarter sales, results, second with

great previously quarter continued the From XXXX a this into to commercials Gvoke of year. territories potential. performance addition the perspective, approximately XX and to of of focused led early organization to success continues Recorlev has long-term pull such, our show endocrinology of a planned Recorlev growth us fourth from forward strong As early field

expect traded been We of this has EU, will globally partner company. a Last growth on our week, accelerate course we announced of Therapeutics, Ogluo. for products and Pharma, by that XXXX. Texas launched the focused A the ensure the these publicly couple in recently acquired the words biopharmaceutical U.K.-based Arecor U.K. and of over Ogluo commercialization

efforts Having in the is millions in a look diabetes forward and diabetes and We're view. working acquisition partner. well the forward company positive patients for of a commercial dedicated levothyroxine, with potential and commercial the to in our continue hands levothyroxine -- few weekly, to very step as mentioned Phase the forward. going space XeriSol previously, and ensure with of no pleased activities last development very capitalized are to will in a Ogluo I support having our our with and subcutaneous once our as X U.K. the Arecor We candidate. product Arecor the we're a EU closely we we perspective, a about smooth the cohort of to study transition dosed commercial disruption of From the pharmacokinetics words

dose support developing having a collect from the point agreed an plan data based This early we our a X, of to X data which hypoglycemia information on with and our meeting we additional weekly candidate have provide FDA of strategy, in regarding the anticipate induced registration this the our latest range the Phase of This program for And this is Exercised the with X proportionality once XXXX. Phase level part a assess an Phase we potential for using all have increased earlier data early later compile will to in product FDA, year. are that dosing. we will order discussions an FDA. us request starting our in should important additional the doses with quarter. data utilization an study X of fourth confidence to We

reviewed this study of as initiation cost and and that initiation We of the the the commercial year, that program are of is requirements EIH assessment from being the FDA the later of clinical consideration. process of our in taking development into the opportunity further EIH prioritization study. That part said, we've gotten and planning

turn for reiterate I just I to financial the record like our has Before second call to quarter fronts Xeris as on I'd on detail quarter reviewed. performance, several Steve a

And aggressively, our prioritizing and our cash an for clear accelerate to but raise both by affirms are is the we our will are these demonstration the the We remain revenue increasingly spend for breakeven our our that position. to enterprise; a We delivering in ability to equity. we without of expectation achieve ending achieve discipline. with year enterprise, growth we believe additional energetically guidance commitments XXXX two valuable on confident need flow building and cash year-end performance our that

call over this turn I'll Now to Steve.

Steve Pieper

are the increase year. decrease more press key partially morning. for release detail net year XX,XXX same a growth prior in everyone. remarks This continued morning, product patient revenue over financial same by on the a last explain driven $XX.X a both which my which than to net prescriptions pricing. to I This XX% was by pricing, few increase, revenue first demand representing later. same a year, Good or of for a the was quarter, compared Gvoke issued focus starts partially a increase, the prescriptions pro decrease for will increase compared second period again period Paul. in to down increase which quarter in underlying was it growth topping Recorlev. million XX% to by the $XX.X patient details was Year-to-date XX% was the year. QX, time, a offset by by increase, Gvoke prior for million increase, will in last net more net and Breaking This same on last the in I this basis. was driven for compared $XX.X in strong and XX% revenue driven growth results, Keveyis a than million XX% the or the period the on Thanks, quarter year therapy Total of for by Gvoke net forma product, was a compared offset

the this Let for more in me pricing context decrease provide on net Gvoke year.

As portion discussed our is to adjustments relative This actual a made price net based last returns the of quarter, reserved decrease to year. we last on results. driving

Additionally, maintain in that the latter patients made are resulting half that to to Gvoke, decisions of started in net order These commercial regarding unrestricted access our have payer impact rebates. in rebates pricing strategy government higher, to we for and continue want our QX.

continue the expect mix. Gvoke begin once consistent new grow Looking to course payer pricing of QX payer the all a to of net take forward, agreements stabilize demand expect effect, to assuming we we in and to

pro year Keveyis increase, pro Keveyis. net a the same a on compared forma forma to same period was million $XX.X million year to quarter the Moving a for XX% increase, year or a basis, to basis. Keveyis revenue basis. $XX.X last On XX% or date last a to compared the was net on period revenue

coupled continue increases on net see Keveyis. We contributed number These this increases patient patients pricing of with growth. to to increase in revenue the a

confident Looking forward, Keveyis and are business. our to ability to continue in we grow maintain our

was revenue quarter net Moving year-to-date. $X.X million million or $X Recorlev. Recorlev launched to Recently for the

We our performance financial are pleased through with initial June.

weekly the are patients given of of We into growth encouraged also by referrals Recorlev coming therapy. outlook new the and

product are million revenue of $XXX guidance net million. mentioned, reaffirming $XXX our to we of Paul As

personnel to months the personnel the the for related compared as same ended The of to XX, XXXX, Moving period XX, increase six year. expenses third lower $X.X marketing $XX.X in increase million six for well costs costs. increased as prior by development development the and sold of ended million primarily million, inclusion in of P&L, to to of the by increased increased months expansion by due and Keveyis XXXX, X% cost The the compared of the June of driven general commercial Selling, for was our approximately company XX% launch. by was and XXXX. and $X.X primarily months ended by driven million higher offset was Gvoke Recorlev same Recorlev roughly increase the product down spend XXXX. products, infrastructure. or We six quarter roughly This Research costs. XX, and sales goods mix expenses XXXX also $XX.X or June increase administrative the our period driven June XXXX, compared increased product incurred field $XX.X in related incurred increased million costs in the an

As of had cash XXXX. compared million million, June investments XX, total XXXX, $XXX.X and short-term $XXX.X Xeris equivalents XX, cash, at to March of

We position. in a strong are cash

$XXX communicated Hayfin this consistent cash and to plan forward year under with prior $XX $XX million. the finished million year available we guidance to facility end draw and the Looking additional previously million within of our guidance, the of our debt by

cash our year-end will breakeven call back constructed I now the as our turn position fund operations to cash to Paul. adequately XXXX. flow currently expect We to by

Paul Edick

Steve. Thanks,

myself of questions. will now first just heard take operational Operator, track commercial Steve, you As from execution we're has we one on XXXX steady to and achieve growth been guidance. and our of both and the half and

Operator

you question SVB from Our Instructions] Ruiz Thank comes Roanna [Operator Securities. from Q&A. for first our

Your ahead. open. line Please is go

Roanna Ruiz

Great. morning, Good everyone.

price. me: XQ relative create first little see seeing? was So bit questions magnitude quarter expect into a on the and change that little curious price trend impact do two the for Could of in bit about to you're Gvoke, net And quick the or normalized? on that a about the talk you net you I sales

Steve Pieper

Yes.

So, Roanna, things, couple just things -- at from the quarter-over-quarter if look it perspective, on going of a there's of couple we a impact were there.

related in that didn't quarter. quarter, European sales to the our was Tetris So second the at in was that first order repeat we That our had stocking -- a actually to revenue time. the to partner,

net little that to that adjustment of last As remind a north first to had this quarter-over-quarter a of reversal half of last in the half ultimately we everybody, the was our included That's last first impacted returns pricing, so we then in terms based had million, Gvoke that year our year, And discussed on quarter, So our $X we growth. an line. in year revenue in that of had actual we increased the our reserve returns. just

drag decisions net expect bit a the around payer We second quarter expect that once we that, kind that on happened that's agreements through our What pricing. we of, was net full nothing those, second material stabilize. quarter actually expect a and in basis normalized. our was in made the on But of a third flush terms quarter may will a that third pricing from the couple It points, that price. material. around quarter the balance our I in percentage but of movement as to wouldn't a quarter

Roanna Ruiz

to process dose? might maintenance early that Could that great. a Recorlev? about do estimate to their ask Recorlev. it’s ideal for little the And wanted individual it patients take get And Okay, specific are Helpful. how to titration a long bit then you're you observing receiving patients question you discuss that

Paul Edick

it's to ask assumptions to me little may our Shannon help titration I clinical in studies. about the XXX The average clinical people were original of question, closer Paul. with to milligrams. on dose is this because based And on Hey, And he John it. the Roanna, an studies, got --

the to routine prescribed patients the in expect would you study, very return office controlled and and basis. scheduled a on clinical it's As is

in takes of the and we easy patients don't a titration normal frequently and managing pretty you go as actuality controlled that context. back So the It's to titration wild in offices have it longer. the little in practice, In way environment. a seeing a the say

it's the titration I Right end is But given starting going, seeing the think average, on anticipated, now, begin much the would pretty than still as they're we're we'll it's of think dose had at that So how one we sense titrate to slower a but agree, quarter John up. in, that one to quarter. better people closer get year. basically we of I little have we're far, a

Roanna Ruiz

Thanks. Great, helpful.

Operator

Our comes H.C. question Wainwright. Oren from next from Livnat

Your line is open.

Oren Livnat

of a have I Thanks. questions. couple

to on us able the more of regards guess what you proportion drugs? -- And require coverage some you of a patients acceleration referrals know, sort in I dig success or they getting indefinite are of see you give those coverage? to I on be and I with follow-up. on successfully volume companies expecting Insurance And drug? Gvoke you And Just or of color funnel, any getting authorization Or month every into and quickly seeing Are what sort further, to guess patients chronic, to of and into your prescriptions, renewal that that? hub Are are kind requirements to sort follow-up to you are Recorlev. for services? the have or know, of, getting authorized. seeing

Steve Pieper

process from they're Oren prescription-based not payer. and the is continuous it's start then approved a process on I'll process, the Yes. it's the from patient once end, renewal it's on a therapy, And by there. really therapy a

renew seen You we being process the prescription, Coverage we hurdles the we're a successful don't haven't far, of but getting through in anticipated, we've through to had so not reasonably efficiently. patients haven't far, are as most at pretty lot There losses the through and category. least we have insurance we’re process. everybody so put that at getting the it them

continue on want seeing referrals competitive know of going volume, an to disclose rapid to we you rate. we're increasing in We're increase give terms In seeing where competitors thing to patients patient numbers. we'll that at We not to convert referrals drug we dollars. we're don't think our that's are, and

Oren Livnat

in you to starting and maintain Okay. this is if that think updated said up thoughts this for script general impact Impressive Keveyis any And year. product expectation consensus competition? and/or product grow meant the a you couple potential I fact of quarter-over-quarter I more in investing on And and a encouraging. I'm the actually. emphasized And looking your times franchise. in this view? erosion of for you you behind wondering any timing That's runway quarter next the nicely you're follow-up have Are longer

Steve Pieper

The answer to yes. your question end at the is

are a We in the of investing product more healthy runway. anticipation behind

We coming. is competitive that any any seen product evidence haven't there

And the lot hard specialty of to the it’s haven't maintain ultra we up in business we a the we've said an a generic them We're as point are find. that's seen have ones including what. believe no one necessary. repeatedly, a evidence pharmacy. if competitor, can case. end We rare that believe some And and to this matter own at grow generic feel of that's Patients we face of reason to disease, It's authorized only finding our we generic.

So we the could to product. well we and Keveyis exclusivity we company believe full that knowing and the lose bought grow was going

Oren Livnat

Thank Appreciate the you. color.

Operator

next David Our Amsellem question comes Piper from Sandler. from

open. Your is line

David Amsellem

Thanks.

anecdotally talk racemic, we So Number the hearing just ready-to-use penetration as are where one. are so about ketoconazole, just had the just about think overall two what's switches that's they specifically, from can Recorlev. term, your of you And, is or patients? receptivity, a these de number a what you're modalities. from practitioners about view And from patients couple, novo on and just know, they in you overall Gvoke longer in know, field coming you

You it of, wrench the threw seems pandemic, into kind uptake. know, of, like sort a

thinking how sort are you of longer growth penetration overall? ready-to-use know, term? it do Thank in And emerging more just about now you it, of you just these that we're expect you. from So modalities

Paul Edick

are with high, getting interested Thanks, the It's very receptivity start We're been has the in great Recorlev product. I'll The at beginning to great. doctors been David. very reception. right Recorlev.

de the we're everywhere, where from getting of patients, switch terms we're In patients, getting getting we're novo them we patients. getting are

valuable as alternative this see eager use. doctors to they're a that So and

early We're we're basically actual with selling. quarter So very very of pleased days. one

Moving on to Gvoke.

impact right, category the the pandemic, a has the pandemic the The grow. for maybe continued the move to grown and ready-to-use period, of You're throughout said, has -- to category. on did grown it's the the but throughout the single-digits to have a dip an that growth category

that the recently see happen just seen impossible announced of I forever. kits it. all with use. see as to you that kit speaks Lilly this volumes to think market, we've what's Lilly around from commitment to the are discussed, kit, really withdraw old to if have the category major interesting about happy a the almost going discontinue things withdraw those That that They're And distribution and by to I withdraw category ready-to-use discontinue that their going going to It'll may we're kit. mean, that But that's a going deal signals of kits of a be in their they're one the been about products to other category. [indiscernible] says companies to distribution great altogether. they're fashion.

David Amsellem

helpful. Okay. And that's

For me seek just follow-up. in a

think that a fact do think of that's migration you more reference Just and kit regarding mean, the discontinuation, to ready-to-use I function that modalities? has is Or Lilly's of a do the it's generic was the Amphastar you the the about drug? really

Paul Edick

day, continue at are product day, the is see think end so market are can At But the the ready-to-use. emphasizing the how reference they're grow. and the the it's for of to end they product generic, of of probably they off the I the don't the matter fact it Lilly I of the Amphastar taking is some both.

to decline. going think it's I

distribution Novo is for good discontinue and withdraw theirs perspective should theirs not and Our well. of patients. Amphastar They're as

David Amsellem

Okay. Thanks, Paul.

Paul Edick

Drive carefully. Thanks, David.

Operator

back I'll Edick, Q&A. to Paul remarks. concludes This CEO for our now final hand

Paul Edick

our for caregivers. strategy that very to support Okay. on you and their Thank call multiple pharmaceutical morning much. Thank the products your we needs to company patients the joining in Thanks categories growth as you. execute meet profitable create this with of everyone continued and a for therapeutic

Operator

for This to call We'd participation. concluded. is now like thank your

Xeris Biopharma (XERS) 10 Aug 222022 Q2 Earnings call transcript